81_FR_69935 81 FR 69740 - Wm. Wrigley Jr. Company; Filing of Color Additive Petition

81 FR 69740 - Wm. Wrigley Jr. Company; Filing of Color Additive Petition

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 195 (October 7, 2016)

Page Range69740-69740
FR Document2016-24208

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Wm. Wrigley Jr. Company, proposing that the color additive regulations be amended to provide for the safe use of calcium carbonate to color hard and soft candy, mints, and chewing gum.

Federal Register, Volume 81 Issue 195 (Friday, October 7, 2016)
[Federal Register Volume 81, Number 195 (Friday, October 7, 2016)]
[Proposed Rules]
[Page 69740]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-24208]



[[Page 69740]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2016-C-2767]


Wm. Wrigley Jr. Company; Filing of Color Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that we have filed a petition, submitted by Wm. Wrigley Jr. Company, 
proposing that the color additive regulations be amended to provide for 
the safe use of calcium carbonate to color hard and soft candy, mints, 
and chewing gum.

DATES: The color additive petition was filed on September 1, 2016.

FOR FURTHER INFORMATION CONTACT: Celeste Johnston, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740-3835, 240-402-1282.

SUPPLEMENTARY INFORMATION: Under section 721(d)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379e(d)(1)), we are giving notice 
that we have filed a color additive petition (CAP 6C0307), submitted by 
Wm. Wrigley Jr. Company, c/o Exponent, 1150 Connecticut Ave. NW., Suite 
1100, Washington, DC 20036. The petition proposes to amend the color 
additive regulations in part 73 (21 CFR part 73) Listing of Color 
Additives Exempt From Certification, to provide for the safe use of 
calcium carbonate to color hard and soft candy, mints, and chewing gum.
    We have determined under 21 CFR 25.32(k) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

    Dated: October 3, 2016.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 2016-24208 Filed 10-6-16; 8:45 am]
 BILLING CODE 4164-01-P



                                                    69740                    Federal Register / Vol. 81, No. 195 / Friday, October 7, 2016 / Proposed Rules

                                                    DEPARTMENT OF HEALTH AND                                DEPARTMENT OF LABOR                                   889–5627). Deliveries (hand, express
                                                    HUMAN SERVICES                                                                                                mail, messenger, or courier service) are
                                                                                                            Occupational Safety and Health                        accepted during the Department of
                                                    Food and Drug Administration                            Administration                                        Labor’s and Docket Office’s normal
                                                                                                                                                                  business hours, 8:15 a.m.–4:45 p.m., ET.
                                                    21 CFR Part 73                                          29 CFR Part 1910                                         Instructions: All submissions must
                                                                                                                                                                  include the Agency name and the
                                                                                                            [Docket No. OSHA–2015–0015]
                                                                                                                                                                  docket number for this rulemaking
                                                    [Docket No. FDA–2016–C–2767]
                                                                                                            RIN 1218–AC94                                         (Docket No. OSHA–2015–0015). All
                                                    Wm. Wrigley Jr. Company; Filing of                                                                            comments, including any personal
                                                                                                            Additional PortaCount® Quantitative                   information you provide, are placed in
                                                    Color Additive Petition                                 Fit-Testing Protocols: Amendment to                   the public docket without change and
                                                                                                            Respiratory Protection Standard                       may be made available online at http://
                                                    AGENCY:    Food and Drug Administration,
                                                    HHS.                                                    AGENCY:  Occupational Safety and Health               www.regulations.gov. Therefore, OSHA
                                                                                                            Administration (OSHA), Department of                  cautions you about submitting personal
                                                    ACTION:   Notice of petition.                           Labor.                                                information such as social security
                                                                                                                                                                  numbers and birthdates.
                                                                                                            ACTION: Notice of proposed rulemaking;
                                                    SUMMARY:   The Food and Drug                                                                                     If you submit scientific or technical
                                                                                                            request for comments.                                 studies or other results of scientific
                                                    Administration (FDA or we) is
                                                    announcing that we have filed a                         SUMMARY:    OSHA is proposing to add                  research, OSHA requests (but does not
                                                    petition, submitted by Wm. Wrigley Jr.                  two modified PortaCount® quantitative                 require) that you also provide the
                                                    Company, proposing that the color                       fit-testing protocols to its Respiratory              following information where it is
                                                    additive regulations be amended to                      Protection Standard. The proposed                     available: (1) Identification of the
                                                                                                            protocols would apply to employers in                 funding source(s) and sponsoring
                                                    provide for the safe use of calcium
                                                                                                            general industry, shipyard employment,                organization(s) of the research; (2) the
                                                    carbonate to color hard and soft candy,
                                                                                                            and the construction industry. Both                   extent to which the research findings
                                                    mints, and chewing gum.                                                                                       were reviewed by a potentially affected
                                                                                                            proposed protocols are variations of the
                                                    DATES:  The color additive petition was                 existing OSHA-accepted PortaCount®                    party prior to publication or submission
                                                    filed on September 1, 2016.                             protocol, but differ from it by the                   to the docket, and identification of any
                                                                                                            exercise sets, exercise duration, and                 such parties; and (3) the nature of any
                                                    FOR FURTHER INFORMATION CONTACT:                                                                              financial relationships (e.g., consulting
                                                    Celeste Johnston, Center for Food Safety                sampling sequence. If approved, the
                                                                                                            modified PortaCount® protocols would                  agreements, expert witness support, or
                                                    and Applied Nutrition (HFS–265), Food                                                                         research funding) between investigators
                                                    and Drug Administration, 5001 Campus                    be alternatives to the existing
                                                                                                                                                                  who conducted the research and any
                                                    Dr., College Park, MD 20740–3835, 240–                  quantitative fit-testing protocols already
                                                                                                                                                                  organization(s) or entities having an
                                                                                                            listed in an appendix of the Respiratory
                                                    402–1282.                                                                                                     interest in the rulemaking. If you are
                                                                                                            Protection Standard. In addition, OSHA
                                                                                                                                                                  submitting comments or testimony on
                                                    SUPPLEMENTARY INFORMATION:       Under                  is proposing to amend an appendix to
                                                                                                                                                                  the Agency’s scientific and technical
                                                    section 721(d)(1) of the Federal Food,                  clarify that PortaCount® fit test devices
                                                                                                                                                                  analyses, OSHA requests (but does not
                                                    Drug, and Cosmetic Act (21 U.S.C.                       equipped with the N95-CompanionTM
                                                                                                                                                                  require) that you disclose: (1) The
                                                    379e(d)(1)), we are giving notice that we               Technology are covered by the approved
                                                                                                                                                                  nature of any financial relationships you
                                                    have filed a color additive petition (CAP               PortaCount® protocols.
                                                                                                                                                                  may have with any organization(s) or
                                                    6C0307), submitted by Wm. Wrigley Jr.                   DATES: Submit comments to this                        entities having an interest in the
                                                    Company, c/o Exponent, 1150                             proposal, including comments to the                   rulemaking; and (2) the extent to which
                                                    Connecticut Ave. NW., Suite 1100,                       information collection (paperwork)                    your comments or testimony were
                                                    Washington, DC 20036. The petition                      requirements, by December 6, 2016.                    reviewed by an interested party prior to
                                                    proposes to amend the color additive                    ADDRESSES: Written comments. You may                  its submission. Disclosure of such
                                                    regulations in part 73 (21 CFR part 73)                 submit comments, identified by Docket                 information is intended to promote
                                                    Listing of Color Additives Exempt From                  No. OSHA–2015–0015, by any of the                     transparency and scientific integrity of
                                                    Certification, to provide for the safe use              following methods:                                    data and technical information
                                                    of calcium carbonate to color hard and                     Electronically: You may submit                     submitted to the record. This request is
                                                    soft candy, mints, and chewing gum.                     comments and attachments                              consistent with Executive Order 13563,
                                                                                                            electronically at http://                             issued on January 18, 2011, which
                                                      We have determined under 21 CFR                       www.regulations.gov, which is the                     instructs agencies to ensure the
                                                    25.32(k) that this action is of a type that             Federal e-Rulemaking Portal. Follow the               objectivity of any scientific and
                                                    does not individually or cumulatively                   instructions online for making                        technological information used to
                                                    have a significant effect on the human                  electronic submissions.                               support their regulatory actions. OSHA
                                                    environment. Therefore, neither an                         Fax: If your submissions, including                emphasizes that all material submitted
                                                    environmental assessment nor an                         attachments, are not longer than 10                   to the rulemaking record will be
                                                    environmental impact statement is                       pages, you may fax them to the OSHA                   considered by the Agency to develop
                                                    required.                                               Docket Office at (202) 693–1648.                      the final rule and supporting analyses.
mstockstill on DSK3G9T082PROD with PROPOSALS




                                                      Dated: October 3, 2016.                                  Mail, hand delivery, express mail,                    Docket: To read or download
                                                                                                            messenger, or courier service: You must               comments and materials submitted in
                                                    Dennis M. Keefe,
                                                                                                            submit your comments to the OSHA                      response to this Federal Register notice,
                                                    Director, Office of Food Additive Safety,               Docket Office, Docket No. OSHA–2015–                  go to Docket No. OSHA–2015–0015 at
                                                    Center for Food Safety and Applied Nutrition.           0015, U.S. Department of Labor, Room                  http://www.regulations.gov or to the
                                                    [FR Doc. 2016–24208 Filed 10–6–16; 8:45 am]             N–2625, 200 Constitution Avenue NW.,                  OSHA Docket Office at the address
                                                    BILLING CODE 4164–01–P                                  Washington, DC 20210, telephone (202)                 above. All comments and submissions
                                                                                                            693–2350 (OSHA’s TTY number is (877)                  are listed in the http://


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Document Created: 2018-02-13 16:31:27
Document Modified: 2018-02-13 16:31:27
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionNotice of petition.
DatesThe color additive petition was filed on September 1, 2016.
ContactCeleste Johnston, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740-3835, 240-402-1282.
FR Citation81 FR 69740 

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